(373 days)
No
The summary describes a standard enzyme immunoassay for detecting methamphetamine in oral fluid. There is no mention of AI, ML, or any computational methods that would suggest their use in the device's operation or data analysis. The performance studies focus on traditional analytical validation methods.
No
This device is an in vitro diagnostic assay intended for the qualitative and semi-quantitative analysis of methamphetamine in human oral fluid. It provides preliminary analytical test results and is not used to treat or prevent a disease or condition.
Yes
This device is intended for "In Vitro Diagnostic Use" and is described as an "enzyme immunoassay" for the "qualitative and semi-quantitative analysis of methamphetamine in human oral fluid." Its purpose is to provide "preliminary analytical test result(s)" for detecting a substance in a biological sample to aid in a diagnosis or monitoring, which falls under the definition of a diagnostic device.
No
The device is an in-vitro diagnostic assay that involves chemical reagents and a collection device, which are hardware components. The description focuses on the performance of the assay and collection method, not solely on software functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use."
- Device Description: The "Device Description" section also states: "The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an in-vitro test..."
- Purpose: The device is intended to detect the presence of methamphetamine in human oral fluid samples, which is a diagnostic test performed outside of the body (in vitro).
- Clinical Analyzers: The assay is intended for use with clinical analyzers, which are typically used for in vitro diagnostic testing in laboratories.
- Laboratory Use: The "Intended User / Care Setting" is listed as "For use in laboratories," which is a common setting for IVD testing.
All of these points clearly indicate that this device is designed and intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use.
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 50 ng/mL in neat oral fluid collected by Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of methamphetamine in human oral fluid with clinical analyzers. This assay is calibrated against d-methamphetamine.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
Product codes
LAF
Device Description
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an in-vitro test to detect the presence of methamphetamine in human oral fluid samples collected by Quantisal or Quantisal II Oral Fluid Collection Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human oral fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For use in laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
Study Type: Precision study
Sample size: 60 determinations for each concentration, 2 runs per day over 15 days using 2 collection devices per run on 1 lot of reagent and 1 lot of Quantisal and 1 lot of Quantisal II oral fluid collection devices (N=60). An additional 20-day study was performed on 3 lots of assay reagent.
Key results: The study established the repeatability of the testing system, including assay and oral fluid collection device.
Specificity and Cross-Reactivity:
Study Type: Specificity and Cross-Reactivity
Key results: Structurally and functionally similar compounds were spiked into drug free pooled oral fluid. The study verified the cross reactivity of the methamphetamine assay to related drugs and drug metabolites, in both the qualitative and semi-quantitative modes.
Interference - Structurally Unrelated Compounds:
Study Type: Interference
Key results: Structurally unrelated compounds were evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free oral fluid containing methamphetamine at ±25% of the cutoff. At the levels tested, there was no interference with structurally unrelated compounds.
Interference - Endogenous Compounds and Exogenous Compounds:
Study Type: Interference
Key results: Endogenous compounds and exogenous compounds were evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free oral fluid containing methamphetamine at ±25% of the cutoff. Additional orally used products were tested by collecting oral fluid using Quantisal and Quantisal II Oral Fluid Collection Devices from volunteers after use of the substances. At the levels tested, there was no interference observed with endogenous compounds, exogenous compounds and orally used compounds.
Interference - pH:
Study Type: Interference
Key results: To evaluate potential interference from the effect of oral fluid pH, device performance in the qualitative and semi-quantitative modes was tested using a range of oral fluid pH values (3.0, 4.0, 5.0, 8.0, 9.0, 10.0 and 11.0). All test samples were prepared in drug free oral fluid containing methamphetamine at ±25% of the cutoff. At the pH levels tested, there was no interference observed for each test mode.
Linearity/Recovery:
Study Type: Linearity/Recovery
Key results: Assay linearity was evaluated in the semi-quantitative mode by spiking a drug free oral fluid pool with a high concentration of methamphetamine. The study confirmed the linear range to be 20-200 ng/mL with a drug recovery percentage of 93.9% to 109.2% across the collection devices.
Methamphetamine Stability in Oral Fluid:
Study Type: Stability
Key results: Drug free negative oral fluid spiked with methamphetamine at +50% of the 50 ng/mL cutoff were collected and stored in Ouantisal II Oral Fluid Collection Devices at 2°C - 8°C. tested by LC-MS/MS at each time point and compared to the baseline concentration result. The test results indicate that oral fluid samples containing methamphetamine are stable for up to 12 months stored in Quantisal or Quantisal II Oral Fluid Collection Device at 2°C - 8°C. Data to support 10-day storage in Quantisal II Oral Fluid Collection Device at ambient temperature 8°C - 25°C were reported in K183048 and K200801.
Calibration Duration:
Study Type: Calibration Duration
Key results: Drug free negative oral fluid spiked with methamphetamine at ±25% of the cutoff were tested in qualitative mode at time points up to 14 days and in semi-quantitative at time points up to 10 days. The test results met acceptance criteria up to 10 days. The recommended frequency of calibration is 7 days.
Method Comparison:
Study Type: Method Comparison
Sample size: 80 deidentified, unaltered clinical oral fluid samples
Key results: The data demonstrate that the design goal of greater than 95% agreement was achieved.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
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December 22, 2021
Immunalysis Corporation Elina Arroyo Manager Regulatory Affairs 829 Towne Center Drive Pomona, California 91767
Re: K203647
Trade/Device Name: SEFRIATM Methamphetamine Oral Fluid Enzyme Immunoassay Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Test System Regulatory Class: Class II Product Code: LAF Dated: October 7, 2021 Received: October 8, 2021
Dear Elina Arroyo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiologial Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
SEFRIA™ Methamphetamine Oral Fluid Enzyme Immunoassay
Indications for Use (Describe) For In Vitro Diagnostic Use.
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 50 ng/mL in neat oral fluid collected by Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of methamphetamine in human oral fluid with clinical analyzers. This assay is calibrated against d-methamphetamine.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
510(k) Number: K203647
A. GENERAL INFORMATION
| Applicant Name: | Immunalysis Corporation
829 Towne Center Drive
Pomona, CA 91767
Establishment # 2020952 |
|------------------|--------------------------------------------------------------------------------------------------|
| Company Contact: | Elina Arroyo, Manager Regulatory Affairs
Immunalysis Corporation |
829 Towne Center Drive, Pomona, CA 91767 USA (224) 361-7080 elina.arroyo@aabbott.com
October 7, 2021 Date Prepared:
B. DEVICE IDENTIFICATION
Trade or Proprietary Names: SEFRIA™ Methamphetamine Oral Fluid Enzyme Immunoassay
Common Name: Methamphetamine Oral Fluid Enzyme Immunoassay
C. REGULATORY INFORMATION
| Device Classification Name: Gas Chromatography, Methamphetamine | |
|---|---|
| Product Codes: | LAF |
| Regulatory Class: | Class II |
| Classification Regulation: | 862.3610 |
| Panel: | Toxicology (91) |
| Predicate Device: | LZI Oral Fluid Methamphetamine Enzyme Immunoassay, LZI Oral Fluid |
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Methamphetamine Calibrators, LZI Oral Fluid Methamphetamine
Controls [K131652]
D. DEVICE DESCRIPTION
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an in-vitro test to detect the presence of methamphetamine in human oral fluid samples collected by Quantisal or Quantisal II Oral Fluid Collection Device.
Methamphetamine is a stimulant drug usually used as a white, bitter-tasting powder or a pill. It is highly addictive and is rarely prescribed. When smoked, the vapor moves from the lungs to the bloodstream causing euphoria, increased energy and alertness, higher confidence, and motivation. Side effects include paranoia, tremors, loss of appetite, mood swings, and neuropsychological effects including deficits in episodic memory, executive functions, information processing speed, motor skills, language, and visuoconstructional abilities. [1] The disposition of methamphetamine in oral fluid has been well documented showing the main drug found after intake is the parent compound. Following single dosing of 10 mg and 20 mg, concentrations over 50 ng/mL of methamphetamine were detected in oral fluid.121 Oral fluid has been shown to be a useful matrix for the analysis of methamphetamine in several areas including workplace drug testing, pain management compliance monitoring, and driving under the influence of drugs. [3],[4],[5]
E. INTENDED USE
For In Vitro Diagnostic Use.
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 50 ng/mL in neat oral fluid collected by Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of methamphetamine in human oral fluid with clinical analyzers. This assay is calibrated against dmethamphetamine.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to
4 Cobb Scott J, Woods SP, Matt GE, Meyer RA, Heaton RK, Atkinson JH, Grant I. Neurocognitive effects of methamphetamine: A critical review and meta-analysis. Neuropsych Review. 2007;17(3):275-297.
2 Huestis MA、Cone EJ. Methamphetamine disposition in oral fluid, plasma and urine. Ann NY Acad Sci. 2007:1098:104-121.
3 Moore C. Oral fluid and hair in workplace drug testing programs: new technology for immunoassays. Drug Test Anal. 2011;3(3):166-168.
4 Moore C. Drug testing and adherence monitoring in pain management: Oral fluid testing. J Opioid Manage. 2015;11(1):69-75.
5 Veitenheimer AM, Wagner JR. Evaluation of oral fluid as a specimen for DUID. J Anal Toxicol. 2017;41(6):517-522.
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obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
F. COMPARISON WITH PREDICATE
| Attribute | Candidate Device
SEFRIA Methamphetamine Oral
Fluid Enzyme Immunoassay | Predicate Device
LZI Oral Fluid
Methamphetamine Enzyme
Immunoassay [K131652] |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Test Principle | Identical | Homogeneous enzyme
immunoassay |
| Calibrated
Against | Identical | d-methamphetamine |
| Assay Materials | Identical | antibody reagent, drug conjugate
reagent |
| Cutoff Level | Identical | 50 ng/mL |
| User
Environment | Identical | For use in laboratories |
| Sample Matrix | Identical | Human oral fluid |
| Reagent Storage | Identical | 2-8°C until expiration date |
| Instrumentation | Identical | Automated clinical chemistry
analyzer |
| Mass
Spectrometry
Confirmation | Identical | Required for preliminary positive
analytical results |
| Differences | | |
| Intended Use | Qualitative and semi-quantitative
analysis of methamphetamine in
human oral fluid collected by
Quantisal or Quantisal II Oral Fluid
Collection Device | Qualitative and semi-quantitative
determination of d-
methamphetamine in neat human
oral fluid collected into the LZI
Oral Fluid Collector |
| Sample
Collection
Device | Oral fluid is collected with the
Quantisal or Quantisal II Oral Fluid
Collection Device. Sample is stored
in a plastic tube containing
preservative buffer with snap cap. | Oral fluid is collected with the LZI
Oral Fluid Collector. Sample is
stored in a plastic tube. |
G. PERFORMANCE CHARACTERISTICS
The following laboratory performance studies were performed to determine substantial equivalence of the SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay to the predicate device. Assay performance was established using the Beckman Coulter AU480 chemistry analyzer.
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1. Precision
Precision study was performed over 15 days, 2 runs per day with 2 collection devices per run (N=60), one replicate per collection device on 1 lot of reagent and 1 lot of Quantisal and 1 lot of Quantisal II oral fluid collection devices. Drug free negative oral fluid was spiked to concentrations of assay cutoff and ±25%, ±50%, ±75%, ±100% of the cutoff and was collected using the collection devices. The spiked concentrations were confirmed by mass spectrometry (LC-MS/MS) before collection. The study established the repeatability of the testing system. including assay and oral fluid collection device. Test results in qualitative and semi-quantitative modes are presented in Tables 1 to 6.
An additional 20-day study was performed on 3 lots of assay reagent to demonstrate the repeatability across multiple reagent lots.
| Concentration
| (ng/mL) | % of Cutoff | # of Determinations | Result |
|---|---|---|---|
| 0 | -100% | 60 | 60 Negative |
| 12.5 | -75% | 60 | 60 Negative |
| 25 | -50% | 60 | 60 Negative |
| 37.5 | -25% | 60 | 60 Negative |
| 50 | Cutoff | 60 | 26 Neg/34 Pos |
| 62.5 | +25% | 60 | 60 Positive |
| 75 | +50% | 60 | 60 Positive |
| 87.5 | +75% | 60 | 60 Positive |
| 100 | +100% | 60 | 60 Positive |
Table 1. Precision - Qualitative - Quantisal
| Table 2. Precision - Semi-Quantitative - Quantisal | ||
|---|---|---|
| -- | ---------------------------------------------------- | -- |
| Concentration
(ng/mL) | % of
Cutoff | # of
Determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|---------------|
| 0 | -100% | 60 | 1.1 | 60 Negative |
| 12.5 | -75% | 60 | 14.2 | 60 Negative |
| 25 | -50% | 60 | 25.3 | 60 Negative |
| 37.5 | -25% | 60 | 39.3 | 60 Negative |
| 50 | Cutoff | 60 | 50.2 | 37 Neg/23 Pos |
| 62.5 | +25% | 60 | 68.9 | 60 Positive |
| 75 | +50% | 60 | 78.9 | 60 Positive |
| 87.5 | +75% | 60 | 93.8 | 60 Positive |
| 100 | +100% | 60 | 112.2 | 60 Positive |
Table 3. Precision - Qualitative - Quantisal II Pad A
| Concentration
| (ng/mL) | % of Cutoff | # of Determinations | Result |
|---|---|---|---|
| 0 | -100% | 60 | 60 Negative |
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| Concentration
| (ng/mL) | % of Cutoff | # of Determinations | Result |
|---|---|---|---|
| 12.5 | -75% | 60 | 60 Negative |
| 25 | -50% | 60 | 60 Negative |
| 37.5 | -25% | 60 | 60 Negative |
| 50 | Cutoff | 60 | 34 Neg/26 Pos |
| 62.5 | +25% | 60 | 60 Positive |
| 75 | +50% | 60 | 60 Positive |
| 87.5 | +75% | 60 | 60 Positive |
| 100 | +100% | 60 | 60 Positive |
Table 4. Precision - Semi-Quantitative – Quantisal II Pad A
| Concentration
(ng/mL) | % of
Cutoff | # of
Determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|---------------|
| 0 | -100% | 60 | 2.4 | 60 Negative |
| 12.5 | -75% | 60 | 14.7 | 60 Negative |
| 25 | -50% | 60 | 25.1 | 60 Negative |
| 37.5 | -25% | 60 | 38.4 | 60 Negative |
| 50 | Cutoff | 60 | 48.6 | 44 Neg/16 Pos |
| 62.5 | +25% | 60 | 63.8 | 60 Positive |
| 75 | +50% | 60 | 74.9 | 60 Positive |
| 87.5 | +75% | 60 | 86.8 | 60 Positive |
| 100 | +100% | 60 | 109.3 | 60 Positive |
Table 5. Precision - Qualitative - Quantisal II Pad B
| Concentration
| (ng/mL) | % of Cutoff | # of Determinations | Result |
|---|---|---|---|
| 0 | -100% | 60 | 60 Negative |
| 12.5 | -75% | 60 | 60 Negative |
| 25 | -50% | 60 | 60 Negative |
| 37.5 | -25% | 60 | 60 Negative |
| 50 | Cutoff | 60 | 31 Neg/29 Pos |
| 62.5 | +25% | 60 | 60 Positive |
| 75 | +50% | 60 | 60 Positive |
| 87.5 | +75% | 60 | 60 Positive |
| 100 | +100% | 60 | 60 Positive |
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| Concentration
(ng/mL) | % of
Cutoff | # of
Determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|---------------|
| 0 | -100% | 60 | 3.8 | 60 Negative |
| 12.5 | -75% | 60 | 14.7 | 60 Negative |
| 25 | -50% | 60 | 24.9 | 60 Negative |
| 37.5 | -25% | 60 | 40.4 | 60 Negative |
| 50 | Cutoff | 60 | 49.0 | 42 Neg/18 Pos |
| 62.5 | +25% | 60 | 65.8 | 60 Positive |
| 75 | +50% | 60 | 78.3 | 60 Positive |
| 87.5 | +75% | 60 | 89.0 | 60 Positive |
| 100 | +100% | 60 | 111.9 | 60 Positive |
Table 6. Precision - Semi-Quantitative - Quantisal II Pad B
2. Specificity and Cross-Reactivity
Structurally and functionally similar compounds were spiked into drug free pooled oral fluid at levels that will yield a result that is equivalent to the cutoff, if cross reacting. The study verified the cross reactivity of the methamphetamine assay to related drugs and drug metabolites, in both the qualitative and semi-quantitative modes. Cross-reactivity test results in qualitative mode are presented in Table 7. Cross-reactivity test results in semi-quantitative mode are presented in Table 8.
| Table 7. Cross-Reactivitv – Qualitative | ||
|---|---|---|
| -- | ----------------------------------------- | -- |
| Compound | Compound
Conc. (ng/mL) | Methamphetamine
Equivalent Conc.
(ng/mL) | Result | Cross-
Reactivity
(%) |
|------------------------------------------------------|---------------------------|------------------------------------------------|--------|-----------------------------|
| l-Methamphetamine | 7,500 | 50 | POS | 0.7 |
| d,l-Methamphetamine | 110 | 50 | POS | 45.5 |
| d-Amphetamine | 8,000 | 50 | POS | 0.6 |
| l-Amphetamine | 40,000 | 75 ng/mL
(greater
than +50%
cutoff) | Agreement (%) |
| Qual. | Positive | 0 | 0 | 4 | 36 | 100% (40/40) |
| | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
| Semi-
Quant. | Positive | 0 | 0 | 4 | 36 | 100% (40/40) |
| | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
Table 16. Method Comparison – Quantisal
Table 17. Method Comparison – Quantisal II "A"
| | Immunoassay
Result | LC-MS/MS Methamphetamine Concentration | | | | |
|-----------------|-----------------------|---------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|------------------------------------------------|---------------|
| | | 75 ng/mL
(greater
than +50%
cutoff) | Agreement (%) |
| Qual. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| Qual. | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
| Semi-
Quant. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| Semi-
Quant. | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
Table 18. Method Comparison - Quantisal II "B"
| Immunoassay
| Result | LC-MS/MS Methamphetamine Concentration | Agreement (%) | ||||
|---|---|---|---|---|---|---|
| 75 ng/mL | ||||||
| (greater | ||||||
| than +50% | ||||||
| cutoff) | ||||||
| Qual. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| Negative | 36 | 4 | 0 | 0 | 100% (40/40) | |
| Semi- | ||||||
| Quant. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
H. CONCLUSION
The information provided in this pre-market notification demonstrates that the SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its intended use.